Regulatory Submissions Jobs in Woburn, MA
Regulatory Submissions Jobs in Woburn, MA
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We are seeking an experienced Senior Director of Compound Development with specialized expertise in radiopharmaceuticals. You will join a dynamic cross-functional team shaping the development and execution of our radiopharmaceutical compound strategy. There is exciting potential for f More...
The Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to activities that span across the scope of clinical development including leading strategic planning and execution of clinical development plans providing support of regulatory subm More...
The Scientific Director International Medical Affairs - Gastroenterology provides medical and scientific strategic and operational input into core medical affairs activities including but not limited to: health-care professional and provider interactions; generation of clinical and sc More...
Position Summary:The Sr. Program Manager-Radiopharmaceutical will focus on the successful initiation execution and monitoring of any Sirtex radiopharmaceutical programs or radiochemistry programs including new product development technical transfer clinical studies regulatory submissi More...
We are seeking an experienced Senior Director of Compound Development with specialized expertise in radiopharmaceuticals. You will join a dynamic cross-functional team shaping the development and execution of our radiopharmaceutical compound strategy. There is exciting potential for f More...
Position Summary:The Sr. Program Manager-Radiopharmaceutical will focus on the successful initiation execution and monitoring of any Sirtex radiopharmaceutical programs or radiochemistry programs including new product development technical transfer clinical studies regulatory submissi More...
The Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to activities that span across the scope of clinical development including leading strategic planning and execution of clinical development plans providing support of regulatory subm More...
The Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to activities that span across the scope of clinical development including leading strategic planning and execution of clinical development plans providing support of regulatory subm More...
Position Summary:The Sr. Program ManagerRadiopharmaceutical will focus on the successful initiation execution and monitoring of any Sirtex radiopharmaceutical programs or radiochemistry programs including new product development technical transfer clinical studies regulatory submissio More...
POSITION SUMMARY:The InHouse Clinical Data Manager will be responsible for a range of data management tasks contributing to the success of clinical trials and regulatory submissions in accordance with Good Clinical Practices and applicable regulations including the Code of Federal Reg More...
General SummaryUnder limited supervision develops analyzes reports and interprets complex financial information to assist management in evaluating and executing the organizations business plans in compliance with the Health Services Cost Review Commission (HSCRC) and Center for Medica More...
The Senior Regulatory Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses providing regulatory support to crossfunctional initiatives as required and dire More...
About This Role:As a Medical Director Clinical Development Immunology you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role you will play a critical part in shaping and advancing clinical programs particula More...
Responsibilities: Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports. Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA). Collaborate with Biostatisticians Data Management and Clinical Teams More...
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